Reader, Be Wary: Sponsors Keep Most 'Complete Response' Letter Content Under Wraps, FDA Says
Agency analysis provides rare portrait of 'complete response' letters while adding to the case for increased transparency.
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Offering a unique peak behind the curtain at data that US FDA is generally prohibited from disclosing and that companies typically choose to keep secret, an agency analysis of two decades worth of refuse-to-file letters found the decisions can add a year and a half to a drug’s approval timeline.
US FDA's complete response letters dropped from 41 in 2016 to 30 in 2017; quality issues as share of total letters continued to climb.
But Amgen is in good company when it comes to companies that choose not to disclose the contents of complete response letters, data from the Pink Sheet's FDA Performance Tracker show. Merck especially holds such information close.